March 6, 2024 -- IAMERS is pleased to announce that IAMERS has been re-appointed as an Observer to the Medical Device Coordination Group (MDCG) of the European Commission for a five- year term.

MDCG provides advice to the Commission and assists the Commission and the EU Member States in the implementation of the European Union Medical Device Regulations, existing EU legislation, programmes and policies. The members of the MDCG are the Competent Authorities of the EU Member States. Subgroups consist of the representatives of the Member States and Observers.

IAMERS is an Observer to the Post-Market Surveillance and Vigilance (PMSV) Working Group which provides assistance to the MDCG on issues related to post-market surveillance, incident reporting and vigilance. The MDCG develops and revises guidance documents and exchanges information on a variety of related topics such as field safety notices and periodic safety update reports.

IAMERS President Diana Upton, upon learning of the re-appointment, commented: “[t]he MDCG are a dedicated group of professionals possessing tremendous expertise and competence in medical device regulation. We are honored to continue to observe on behalf of IAMERS Members. We look forward to keeping abreast of the latest MDR developments and guidances.”

Source: IAMERS

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